A “revolutionary” prenatal care patent is invalidated under the Mayo test

John M. Wang | July 30, 2015

Ariosa Diagnostics, Inc., Et Al. v. Sequenom, Inc., Et Al.

June 12, 2015

Before: Reyna (Opinion author), Linn (Concurring), and Wallach

The Federal Circuit held that the method claims of the asserted patent are invalid as patent-ineligible under 35 U.S.C.S. § 101 because the method claims are directed to naturally occurring phenomena, and do not contain an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent-eligible application.

In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. They then developed a method using known laboratory techniques to amplify and detect a small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. In 2001, Drs. Lo and Wainscoat obtained the “540 patent relating to this method. Then, Sequenom commercialized this method into the MaterniT21 Test, which revolutionized prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques taking samples directly from the fetus or placenta.

Ariosa Diagnostics, Inc. Et Al. (hereinafter “Ariosa”) make and sell non-invasive Paternity Tests used for prenatal diagnosis of certain fetal characteristics. In response to letters threatening claims of infringement, Ariosa filed declaratory judgment actions against Sequenom alleging that they did not infringe the ‘540 patent. Sequenom counterclaimed alleging patent infringement. The district court held that the ‘540 patent was not directed to patentable subject matter, and thus invalid. Sequenom appeals.

Claim 1 of the disputed ‘540 patent is shown as follows:

Claim 1: A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

In determining whether claims of ‘540 patent are patent eligible, the Federal Circuit applied the two-step framework set forth in the Supreme Court case, Mayo Collaborative Services v. Prometheus Laboratories, Inc. The first step is to determine whether the claims at issue are directed to a patent-ineligible concept. If so, the second step is to consider the elements of each claim both individually and as an ordered combination to determine whether additional elements transform the nature of the claim into a patent-eligible application.

In this case, both parties agreed that the ‘540 patent does not claim cffDNA or paternally inherited cffDNA. Instead, the ‘540 patent claims certain methods of using cffDNA. But the Federal Circuit agreed with the district court’s positions that the claims of the ‘540 patent are directed to a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum, which is a naturally occurring non-cellular fetal DNA, as well as ends with a paternally inherited cffDNA, which is also a natural phenomenon. The method of the claims does not create or alter any of the genetic information encoded in the cffDNA. Thus, the Federal Circuit concluded that the claims are directed to matter that is naturally occurring, and meet the first requirement of the “Mayo” test. The Federal Circuit also cites languages in the specification of 054’ patent to support its position.

In addressing the second step of Mayo’s framework, the Federal Circuit considered each elements of the claim 1, and concluded that the amplifying step and the detecting step in claim 1 are well-understood, conventional, and routine steps. However, the majority opinion did not address the ordered combination of the elements, as required by the Mayo test, such as applying the amplifying step and the detecting step to the serum or plasma sample, which had not been done by anyone before. Furthermore, the dependent claims are broad examples of how to detect cffDNA in maternal plasma, which are also well-understood, routine, and conventional, and thus, add no inventive concept to the limitations of claim 1. Therefore, the Federal Circuit concluded that the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention, and meets the second requirement of the Mayo test. Consequently, the Federal Circuit held that the claims of the ‘540 patent at issue are invalid because they are not directed to patent-eligible subject matter. The Federal Circuit also cites languages in the specification of 054’ patent to support its position.

Regarding the principle of preemption, Sequenom argues that there are numerous other uses of cffDNA aside from those claimed in the ‘540 patent, and thus, the ‘540 patent does not preempt all uses of cffDNA. However, the Federal Circuit took the position that while preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. Therefore, the Federal Circuit held that as long as the claims are deemed to disclose patent ineligible subject matter, preemption concerns are fully addressed and made moot.

Judge Linn essentially cloaked a dissent opinion in a concurring opinion. He readily acknowledged that ‘054 patent is related to a meritorious invention, that no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers, and that this meritorious invention deserves and should have been entitled to retain the patent protection. Nevertheless, Judge Linn concurred with the majority opinion because he felt that he was bound by the sweeping language of the Mayo test, even though he admitted that “Sequenom’s invention is nothing like the invention at issue in Mayo.” In Judge Linn’s words, “Sequenom effectuated a practical result and benefit not previously attained, so its patent would traditionally have been valid.” “But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”

Take away

1. Patent drafters should be very careful in using such languages in a specification that may inadvertently render support for non-patentability of the application.

2. Under the sweeping Mayo test, it may not be enough to overcome an ineligible subject matter rejection by claiming a method which applies ordinary techniques to utilize naturally-occurring phenomena, despite that no one had done it before and the method achieved revolutionary results.

3. The principle of preemption can be used to invalidate a patent, but not to validate a patent.

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